Senior Regulatory Affairs Consultant

2 weeks ago

Cincinnati, Ohio, United States TEPHRA Full time
Position Overview:

The selected candidate will collaborate with clients and internal teams to provide top-tier solutions for regulatory submissions.

Support the development of technical documentation (including technical files and design dossiers) for Spine products, ensuring compliance with the new Medical Device Regulation (MDR) in the European Union.


Key Qualifications:
  • In-depth understanding of EU Medical Device regulations and associated guidance documents, along with relevant standards.
  • Proven experience in preparing Technical Files and technical documentation for submission to notified bodies.
  • Capability to engage with cross-functional teams, including R&D, Quality, Labelling, Sterility, Medical, and Clinical departments.
  • Familiarity with Product Lifecycle Management (PLM) systems such as Agile and Windchill.
  • Proficient in MS Office applications including Word, PowerPoint, and Excel.
  • Exceptional communication and interpersonal skills.
  • Strong organizational skills with the ability to manage multiple tasks while maintaining attention to detail.
  • Experience in coordinating with offshore teams, particularly with teams in India.
Responsibilities:

  • Identify and compile reference documents necessary for technical documentation, including design and risk documents, verification/validation documents, standards conformance, and labeling.
  • Adhere to established policies, procedures, and work instructions that support technical documentation activities.
  • Assist in the preparation of Clinical Evaluation Reports, ensuring all required documentation is referenced.
  • Align technical documentation with the OneMD structure as proposed by the MDR team.
  • Prepare technical documentation for submission to and review by Notified Bodies as required.
  • Facilitate global product registration activities by compiling necessary dossiers, submissions, and responses to regulatory bodies.
  • Maintain up-to-date information on global regulatory requirements and the status of product registrations.
  • Ensure adherence to timelines and the achievement of key milestones.
Reporting:
Communicate any issues to management to ensure proper resolution.

Education:
BS Degree
Experience:
4-10 years of relevant experience required for this position.

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